Prediction Using Connected Technologies for Diabetes

NCT03544320 | Completed

• 1 other identifier: 829150
• Study Type: interventional
• Target: 186
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, adults with pre-diabetes will be prospectively enrolled for data collection to design prediction models that integrate electronic health record data and patient-generated activity data. Patients will be randomized to receive either a waist-worn or wrist-worn wearable device for 6 months to capture patient-generated activity data.

Conditions

Pre-Diabetes

Keywords

Pre-diabetes; diabetes; wearable devices; mobile health

Outcome Measures

Primary Outcomes (1)

• Change in hemoglobin A1c

  Change in hemoglobin A1c from baseline to 6 months

  6 months

Secondary Outcomes (1)

• Change in low-density lipoprotein (LDL) levels

  6 months

Other Outcomes (1)

• Hospitalization

  6 months

Study Arms (2)

Activity Monitoring-Wrist worn wearable

ACTIVE COMPARATOR

Participants in the activity monitoring-wrist worn wearable group will be randomly assigned to track their activity using a Fitbit Charge 2 for 6 months.

Device: Activity Monitoring-Wrist worn wearable

Activity Monitoring-Waist-worn wearable

ACTIVE COMPARATOR

Participants in the activity monitoring-waist worn wearable group will be randomly assigned to track their activity using a Fitbit Zip for 6 months.

Device: Activity Monitoring-Waist-worn wearable

Interventions

Activity Monitoring-Wrist worn wearable DEVICE

Participants wear an activity monitor on their wrist.

Activity Monitoring-Wrist worn wearable

Activity Monitoring-Waist-worn wearable DEVICE

Participants wear an activity monitor on their waist.

Activity Monitoring-Waist-worn wearable

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be 18 years or older
• Be able to provide informed consent
• Have a smartphone or tablet compatible with the wearable device smartphone application and be willing to use the wearable device for 6 months
• Baseline hemoglobin A1c of 5.7 to 6.4

You may not qualify if:

• Participants will no be eligible if they have any medical condition or other reason that will likely prohibit them from completing the 6-month study

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

Penn Medicine

Philadelphia, Pennsylvania, 19103, United States

Location

MeSH Terms

Conditions

Glucose Intolerance; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Mitesh S Patel, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The participants will be aware of the two different study arms and the wearable devices used in both. The study investigator will not have not have knowledge of the participants assigned to each arm.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are randomized to one of two wearable devices and will wear that device for the duration of the study.

Study Record Dates

• First Submitted: May 18, 2018
• First Posted: June 1, 2018
• Study Start: July 9, 2018
• Primary Completion: August 1, 2019
• Study Completion: August 1, 2019
• Last Updated: August 29, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)